| 16 Jun 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46 | SCA Pharmaceuticals | Drug | Class II | 1 |
| 11 Jun 2020 | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01 | Hikma Pharmaceuticals USA Inc. | Drug | Class II | 2 |
| 5 Jun 2020 | Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04 | Akorn, Inc. | Drug | Class III | 1 |
| 5 Jun 2020 | metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 4 Jun 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | AVKARE Inc. | Drug | Class II | 2 |
| 2 Jun 2020 | Adams Reserve Sweet & Spicy Seafood Salmon NEY WT 2.5 OZ (73g) UPC code 4313 04950. | Adams Extract & Spice LLC | Food | Class II | 1 |
| 29 May 2020 | Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83 | Pfizer Inc. | Drug | Class II | 1 |
| 29 May 2020 | Healthy Choice Pesto and Egg bowls labeled in the following ways: 1) (for the US market) Healthy Choice Power Bowls Morning Pesto & Egg White Scramble, Net Wt. 7.2 OZ (204 g); UPC 0-72655-00083-4 2) (for the Canadian market) Healthy Choice, Power Bowls, All-Day Breakfast, Pesto & Egg White Scramble, 204 g, UPC 0… | ConAgra Foods, INc. | Food | Class II | 1 |
| 28 May 2020 | Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03. | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 28 May 2020 | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07 | QuVa Pharma, Inc. | Drug | Class II | 1 |
| 28 May 2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42 | Glaxosmithkline Consumer Healthcare Holdings | Drug | Class II | 4 |
| 28 May 2020 | Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478. | AVKARE Inc. | Drug | Class III | 1 |
| 27 May 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1 | Apotex Inc. | Drug | Class II | 1 |
| 26 May 2020 | Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-135-01 | UNICHEM PHARMACEUTICALS USA INC | Drug | Class III | 1 |
| 26 May 2020 | Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30 | Aurobindo Pharma USA Inc. | Drug | Class III | 2 |
| 26 May 2020 | Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97. | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 22 May 2020 | NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-329-01. | Acella Pharmaceuticals, LLC | Drug | Class I | 3 |
| 22 May 2020 | Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. | The Harvard Drug Group | Drug | Class II | 1 |
| 22 May 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02 | Teva Pharmaceuticals USA | Drug | Class II | 3 |
| 21 May 2020 | Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571 | Elekta Limited | Device | Class II | 1 |
| 21 May 2020 | Captain Rusty's Smoked Salmon Dip, A Taste of the Pacific Coast, Keep Refrigerated, 16 oz. | Captain Rusty's Seafood Products LLC | Food | Class I | 5 |
| 20 May 2020 | Leica ARveo and M530 OH6 microscope systems. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 20 May 2020 | La Sonorense Tortilla Factory, Flour Burrito Size, One Dozen, NET WT. 1 lb. 6 oz. (22 oz.) | La Sonorense, Inc. | Food | Class II | 2 |
| 19 May 2020 | Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation. | Philips North America, LLC | Device | Class II | 1 |
| 19 May 2020 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11 | American Health Packaging | Drug | Class II | 1 |
| 19 May 2020 | LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL. | Wuhan Bingbing Pharmaceutical Co., Ltd. | Drug | Class II | 4 |
| 19 May 2020 | Sienna brand 4.25 oz. Cranberry Orange Muffins coded 20 071 31B | BAKE'N JOY FOODS, INC. | Food | Class I | 1 |
| 18 May 2020 | RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. | RAYSEARCH LABORATORIES AB | Device | Class II | 15 |
| 18 May 2020 | Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades. | Carefusion 2200 Inc | Device | Class II | 1 |
| 16 May 2020 | Cherrybrook Kitchen***Gluten Free***Wheat Free***SUGAR COOKIE MIX***NET WT. 13 OZ Event 85741 | Cell-nique Corp | Food | Class II | 1 |
| 15 May 2020 | Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28), f) 30-count (NDC 55289-866-30), g) 60-count (NDC 55289-866-60), h) 120-count (NDC 55289-866-98),… | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 15 May 2020 | Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02 Event 85704 | TRIOVA PHARMACEUTICALS LLC | Drug | Class II | 1 |
| 15 May 2020 | EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion, IA 52302, UPC: 859623000030; 859623000177; 859623000573; Display UPC: 859623000092; 859623000108; 859623000139; 859623000146; 859623000184; 859623000535; 859623001037. | Eco Lips Inc | Drug | Class II | 1 |
| 15 May 2020 | Dragonfly brand Galanga Powder; Net Weight: 5 oz. (142 g) UPC: 7 21557 53337 6 Product of Thailand Distributed by U.S. Trading Company, Hayward, CA 94545-1130 | U.S. Tov, Inc. | Food | Class II | 1 |
| 15 May 2020 | Siete Grain Free Cashew Flour Tortillas NET WT 7 OZ (200g) 8 Count UPC 865336000045 packaged in flexible plastic Event 85698 | GARZA FOOD VENTURES | Food | Class II | 1 |
| 15 May 2020 | Wegmans Tuna Salad, 16 OZ (1 LB) 454 g; UPC: 77890-48147; SELL BY 5/21/20 | Wegmans Food Markets, Inc. | Food | Class II | 4 |
| 14 May 2020 | Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process. | Biomet | Device | Class II | 22 |
| 14 May 2020 | Garlic Sauce; Net Wt. 8LB. (3.62 kg); PJ Item #1104; UPC 26700 16345; Manufactured for: PJ Foods Service, Inc; Louisville, KY 40299, USA. Ingredients: Soybean oil, water, salt, vegetable mono & diglycerides, contains less than 2% of garlic*, natural flavors, soy lecithin, lactic acid, sodium benzoate (a… | Ventura Foods Llc | Food | Class I | 1 |
| 13 May 2020 | Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. | West-Ward Columbus Inc | Drug | Class II | 1 |
| 12 May 2020 | Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 12 May 2020 | Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning. | Med Tec Inc | Device | Class II | 1 |
| 12 May 2020 | Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries. | Medtronic Vascular Galway DBA Medtronic Ireland | Device | Class I | 1 |
| 12 May 2020 | Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s). | Covidien Llc | Device | Class II | 4 |
| 12 May 2020 | Home Style Crab Cakes in a plastic wrapped foam tray, 12 oz. (Four, 3 oz. crab cakes per package). 12 packages per case. Event 85692 | Johnson Sea Products, Inc. | Food | Class II | 1 |
| 11 May 2020 | Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300 | Biomet, Inc. | Device | Class II | 1 |
| 11 May 2020 | VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600… | Ortho-Clinical Diagnostics | Device | Class II | 4 |
| 11 May 2020 | Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05 | Torrent Pharma Inc. | Drug | Class II | 1 |
| 8 May 2020 | Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural Catheter kit permits access to the epidural space for… | Arrow International Inc | Device | Class II | 1 |
| 8 May 2020 | Chili Powder, Mild, Organic is a blend, Item # 90030. Packaged in 1 lb. bags and sold under brand Azure Market. This product contains "Organic Chili Peppers, Salt, Organic Spices, Organic Garlic, Organic Sunflower Oil". The Azure Market label listed the lot # 90030041520 and UPC 8 70722 00251 0. | K F K Seasonings Llc | Food | Class I | 3 |
| 7 May 2020 | Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones. | Stryker GmbH | Device | Class II | 15 |
| 7 May 2020 | MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 7 May 2020 | Wild Harvest Organic Fresh Basil packaged in the following sized plastic containers: Net Wt 2 oz (57g), UPC 11535-50762, Net Wt 0.25 oz. (7g), UPC 11535-50450, Net Wt 0.75 oz. (21g), UPC 11535-50322, Net Wt. 4 oz. (113g), UPC 11535-50323. Distributed by Supervalu, Inc., Eden Prairie, MN 55344 | UNFI General Corporate | Food | Class II | 1 |
| 6 May 2020 | Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J Event 85480 | Endologix, Inc. | Device | Class I | 1 |
| 6 May 2020 | Milkadamia Unsalted Buttery Spread 8 ounces packaged in plastic tub, 6 packaged per case UPC 858045004725 | Jindilli Beverages LLC | Food | Class II | 2 |
| 5 May 2020 | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and… | Zimmer Biomet, Inc. | Device | Class II | 25 |
| 5 May 2020 | ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen. | Olympus Corporation of the Americas | Device | Class II | 1 |
| 5 May 2020 | Plucker's Wing Bar World Famous Wing Sauce Baker's Gold 12 FL OZ. (355 mL) packaged in a glass bottle | Zilks Foods | Food | Class II | 8 |
| 4 May 2020 | AC Powered hospital adjustable bed. Event 85592 | Umano Medical, Inc. | Device | Class II | 1 |
| 4 May 2020 | ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two-three weeks. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 6 |
| 4 May 2020 | BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H965460151 H965460161 H965460161-NP H965460171 H965460181 H965460221 H965460231… | Angiodynamics, Inc. | Device | Class II | 4 |
| 4 May 2020 | Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices. | Resource Optimization & Innovation LLC | Device | Class II | 2 |
| 1 May 2020 | Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235 | Biomet | Device | Class II | 2 |
| 1 May 2020 | RITZ Cheese Cracker Sandwiches , Family Size , (21.6 oz. carton) | Mondelez Global Llc | Food | Class I | 1 |
| 30 Apr 2020 | DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS | Diasol, Inc | Device | Class II | 1 |
| 30 Apr 2020 | Pressure Monitoring Set, C-PMS, G02838 | Cook Inc. | Device | Class II | 2 |
| 30 Apr 2020 | Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. | Elekta, Inc. | Device | Class II | 1 |
| 30 Apr 2020 | Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 10094135 Product Usage: Artis is a family of dedicated… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 30 Apr 2020 | Centrella Smart+ Bed, Catalog Number P7900 | Hill-Rom, Inc. | Device | Class II | 1 |
| 29 Apr 2020 | Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing. Event 85561 | Name withheld | Device | Class II | 1 |
| 28 Apr 2020 | Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. | GE Healthcare, LLC | Device | Class II | 2 |
| 27 Apr 2020 | Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation. | Philips North America, LLC | Device | Class II | 1 |
| 27 Apr 2020 | DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201, 00815098020225, 00815098020232 Product Usage: Automated External… | Defibtech, LLC | Device | Class II | 3 |
| 26 Apr 2020 | Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures. | Argon Medical Devices, Inc | Device | Class II | 1 |
| 24 Apr 2020 | Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other… | Physio-Control, Inc. | Device | Class II | 2 |
| 24 Apr 2020 | ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy. | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 24 Apr 2020 | Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler. | Medtronic Sofamor Danek USA Inc | Device | Class II | 3 |
| 23 Apr 2020 | OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer | Olympus Corporation of the Americas | Device | Class II | 1 |
| 23 Apr 2020 | ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 23 Apr 2020 | ProxiDiagnost N90, UDI 706100 | Philips North America, LLC | Device | Class II | 1 |
| 22 Apr 2020 | ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 22 Apr 2020 | smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component. | Smith & Nephew, Inc. | Device | Class II | 6 |
| 22 Apr 2020 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is… | Name withheld | Device | Class II | 2 |
| 21 Apr 2020 | Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation | Philips North America, LLC | Device | Class II | 1 |
| 20 Apr 2020 | Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy. | ROi CPS LLC | Device | Class II | 1 |
| 20 Apr 2020 | TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. | Trividia Health, Inc. | Device | Class II | 1 |
| 20 Apr 2020 | Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor used in pairs to transmit a controlled electrical shock from an… | Philips North America, LLC | Device | Class II | 1 |
| 20 Apr 2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. | Fresenius Kabi USA, LLC | Drug | Class I | 2 |
| 17 Apr 2020 | Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 17 Apr 2020 | Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. | Baxter Healthcare Corporation | Device | Class II | 4 |
| 17 Apr 2020 | Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose… | Biomet, Inc. | Device | Class II | 13 |
| 17 Apr 2020 | Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS. | Alcon Research LLC | Device | Class II | 1 |
| 15 Apr 2020 | Absorb Health Advanced Joint Relief Joint Health; 510mg; 90 CAPSULES; Manufactured for: Absorb Health, 106 Countryside St NW, Supply, NC 28462 UPC 79056992863 Event 85242 | Absorb Health LLC | Food | Class II | 1 |
| 13 Apr 2020 | Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring… | Philips North America, LLC | Device | Class II | 2 |
| 13 Apr 2020 | Sterile Custom Packs to be used in surgical procedures. | American Contract Systems | Device | Class II | 14 |
| 10 Apr 2020 | Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001 | Medtronic Inc. | Device | Class II | 1 |
| 9 Apr 2020 | CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21 | CooperSurgical, Inc. | Device | Class II | 1 |
| 8 Apr 2020 | therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121 | Qiagen Sciences LLC | Device | Class II | 1 |
| 7 Apr 2020 | FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N… | Name withheld | Device | Class II | 2 |
| 7 Apr 2020 | FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation. | Name withheld | Device | Class II | 3 |
| 7 Apr 2020 | FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to… | Name withheld | Device | Class II | 3 |
| 6 Apr 2020 | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures,… Event 85599 | Name withheld | Device | Class II | 1 |
| 3 Apr 2020 | VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer blood from a syringe into the evacuated blood collection tube. Event 85411 | Name withheld | Device | Class II | 1 |
| 3 Apr 2020 | Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 | Heartware, Inc. | Device | Class I | 5 |
| 2 Apr 2020 | Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. | Insulet Corporation | Device | Class II | 2 |
| 2 Apr 2020 | Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808. | GE Healthcare, LLC | Device | Class II | 1 |
| 2 Apr 2020 | Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified… | Abbott Laboratories | Device | Class II | 1 |
| 2 Apr 2020 | OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. | Osteomed, LLC | Device | Class II | 12 |
| 31 Mar 2020 | Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666 | Spectranetics Corporation | Device | Class II | 1 |
| 25 Mar 2020 | Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A, Event 85497 | Name withheld | Device | Class II | 1 |
| 23 Mar 2020 | Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics Technologies AS,… Event 85313 | Abbott Diagnostics Technologies AS | Device | Class II | 1 |
| 23 Mar 2020 | Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079 Event 85424 | INARI MEDICAL | Device | Class II | 1 |
| 17 Mar 2020 | safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 | Radiometer Medical ApS | Device | Class II | 3 |
| 17 Mar 2020 | Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147 | Applied Medical Resources Corp | Device | Class II | 4 |
| 9 Mar 2020 | Bin Butternut Squash, Bulk, Raw Product in Bins / 4, 5lb packages in each case Event 85732 | Coastal Sunbelt Produce Co. Inc. | Food | Class II | 1 |
| 3 Mar 2020 | Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain,… | Canon Medical System, USA, INC. | Device | Class II | 3 |
| 29 Jan 2020 | ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma. | Beckman Coulter Inc. | Device | Class II | 1 |
| 28 Jan 2020 | JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable spikes (spike rail) aids in… | Smith & Nephew, Inc. | Device | Class II | 2 |
| 22 Jan 2020 | FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT FA Plus 410852/BACT/ALERT FN Plus 410853/BACT/ALERT PF Plus 259790/BACT/ALERT SN Product Usage: is a qualitative multiplexed nucleic… | BioFire Diagnostics, LLC | Device | Class II | 2 |
| 14 Jan 2020 | Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. | Ormco/Sybronendo | Device | Class II | 1 |
| 9 Jan 2020 | 085-CH-550-35 Cheese Whiz-Small Bag, 085-CH-550-35: 35 lbs. Multiwall bags . | World Flavors, Inc. | Food | Class II | 2 |
| 26 Dec 2019 | Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100 | Cardinal Health Inc. | Device | Class II | 6 |
| 23 Dec 2019 | Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225. Event 85498 | Name withheld | Device | Class II | 1 |
| 19 Dec 2019 | STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach. | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 17 Dec 2019 | Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers) | Quest Medical, Inc. | Device | Class II | 1 |
| 11 Dec 2019 | Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II) Event 85533 | Abaxis Inc | Device | Class II | 1 |
| 5 Dec 2019 | Mazor X Surgical System Positioner Type II, REF: ASM0214-02 | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 21 Nov 2019 | ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. | Radiometer Medical ApS | Device | Class II | 2 |
| 14 Nov 2019 | HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility or typing.… | Hardy Diagnostics | Device | Class II | 1 |
| 4 Nov 2019 | Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen | Immuno-Mycologics, Inc | Device | Class II | 1 |
| 23 Oct 2019 | GENTLEWAVE REF: FG-002-0001 Event 85593 | Sonendo Inc | Device | Class II | 1 |
| 11 Oct 2019 | Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography… | TELEFLEX MEDICAL INC | Device | Class II | 2 |
| 10 Oct 2019 | 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H | Biocare Medical, LLC | Device | Class II | 1 |
| 10 Oct 2019 | Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214 | Hologic, Inc | Device | Class II | 1 |
| 7 Oct 2019 | Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components) | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 4 Oct 2019 | Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in | Ventana Medical Systems Inc | Device | Class II | 1 |
| 30 Aug 2019 | Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. | Spacelabs Healthcare, Inc. | Device | Class II | 1 |
| 19 Aug 2019 | da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery. | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 30 Jul 2019 | RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners. | Eizo Corporation | Device | Class II | 2 |
| 29 Jul 2019 | Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an… Event 85301 | MOTEK MEDICAL B.V. | Device | Class II | 1 |
| 19 Jul 2019 | NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619 | Nobel Biocare Usa Llc | Device | Class II | 1 |
| 8 Jul 2019 | BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in… | Becton, Dickinson and Company, BD Biosciences | Device | Class II | 3 |
| 14 Jun 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F | Bard Peripheral Vascular Inc | Device | Class II | 2 |
| 30 May 2019 | Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled. | Clinical Innovations, LLC | Device | Class II | 1 |
| 28 May 2019 | Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component… | Nobel Biocare Usa Llc | Device | Class II | 1 |
| 20 May 2019 | Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices. | Medtronic Inc. | Device | Class II | 1 |
| 30 Apr 2019 | Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems. | Beckman Coulter Inc. | Device | Class II | 6 |
| 24 Apr 2019 | ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1) Manual - Product Usage: The surgical paddle… | Boston Scientific Neuromodulation Corporation | Device | Class II | 7 |
| 19 Apr 2019 | IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. | Philips Healthcare Informatics, Inc. | Device | Class II | 1 |
| 1 Apr 2019 | da Vinci SP surgical system | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 7 Jan 2019 | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15… | Acuity Surgical Devices, LLC | Device | Class II | 2 |
| 30 Nov 2018 | System, Tomography Computed Emmission | GE Healthcare, LLC | Device | Class II | 2 |
| 21 Aug 2018 | Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | Genicon, Inc. | Device | Class II | 14 |
| 19 Dec 2017 | PerkinElmer 226 Sample Collection Device | PerkinElmer Health Sciences, Inc. | Device | Class III | 1 |